IT202000013156A1 - LIQUID OPHTHALMIC COMPOSITION INCLUDING AN AQUEOUS EXTRACT OF SPIRULINA PLATENSIS. - Google Patents
LIQUID OPHTHALMIC COMPOSITION INCLUDING AN AQUEOUS EXTRACT OF SPIRULINA PLATENSIS. Download PDFInfo
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- IT202000013156A1 IT202000013156A1 IT102020000013156A IT202000013156A IT202000013156A1 IT 202000013156 A1 IT202000013156 A1 IT 202000013156A1 IT 102020000013156 A IT102020000013156 A IT 102020000013156A IT 202000013156 A IT202000013156 A IT 202000013156A IT 202000013156 A1 IT202000013156 A1 IT 202000013156A1
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- 239000000203 mixture Substances 0.000 title claims description 48
- 239000006286 aqueous extract Substances 0.000 title claims description 29
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- KIUKXJAPPMFGSW-DNGZLQJQSA-N (2S,3S,4S,5R,6R)-6-[(2S,3R,4R,5S,6R)-3-Acetamido-2-[(2S,3S,4R,5R,6R)-6-[(2R,3R,4R,5S,6R)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-2-carboxy-4,5-dihydroxyoxan-3-yl]oxy-5-hydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-3,4,5-trihydroxyoxane-2-carboxylic acid Chemical compound CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O[C@H]3[C@@H]([C@@H](O)[C@H](O)[C@H](O3)C(O)=O)O)[C@H](O)[C@@H](CO)O2)NC(C)=O)[C@@H](C(O)=O)O1 KIUKXJAPPMFGSW-DNGZLQJQSA-N 0.000 description 1
- QTBSBXVTEAMEQO-UHFFFAOYSA-M Acetate Chemical compound CC([O-])=O QTBSBXVTEAMEQO-UHFFFAOYSA-M 0.000 description 1
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0048—Eye, e.g. artificial tears
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/66—Microorganisms or materials therefrom
- A61K35/74—Bacteria
- A61K35/748—Cyanobacteria, i.e. blue-green bacteria or blue-green algae, e.g. spirulina
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/40—Cyclodextrins; Derivatives thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Inorganic Chemistry (AREA)
- Biotechnology (AREA)
- Mycology (AREA)
- Engineering & Computer Science (AREA)
- Molecular Biology (AREA)
- Microbiology (AREA)
- Ophthalmology & Optometry (AREA)
- Medicinal Preparation (AREA)
Description
DESCRIZIONE dell?invenzione avente per titolo: DESCRIPTION of the invention entitled:
?Composizione oftalmica liquida comprendente un estratto acquoso di Spirulina platensis? ?Liquid ophthalmic composition comprising an aqueous extract of Spirulina platensis?
RIASSUNTO SUMMARY
La presente invenzione riguarda una composizione oftalmica liquida, utile ad esempio come umettante, comprendente quale principio attivo, un estratto acquoso di Spirulina platensis eventualmente addizionato con altri estratti di detto microorganismo, in presenza di un opportuno veicolo ed eventuali eccipienti. L?invenzione ha anche per oggetto l?uso del detto estratto acquoso nel trattamento di svariate affezioni dell?occhio. The present invention relates to a liquid ophthalmic composition, useful for example as a humectant, comprising as active ingredient an aqueous extract of Spirulina platensis optionally added with other extracts of said microorganism, in the presence of a suitable vehicle and optional excipients. The invention also relates to the use of said aqueous extract in the treatment of various eye conditions.
CONTESTO DELL?INVENZIONE BACKGROUND OF THE INVENTION
La Spirulina platensis, o Arthrospira platensis, detta anche microalga Spirulina, ? un microorganismo di una specie appartenente alla classe dei cianobatteri che, in natura, vive in laghi di acqua dolce con acque alcaline e calde. ? nota sin dall'antichit? dai popoli delle regioni tropicali per le sue innumerevoli propriet?. Spirulina platensis, or Arthrospira platensis, also called Spirulina microalgae, is a microorganism of a species belonging to the class of cyanobacteria which, in nature, lives in freshwater lakes with alkaline and warm waters. ? known since antiquity? by the peoples of tropical regions for its innumerable properties.
Oggi ? conosciuta e utilizzata in tutto il mondo come integratore alimentare, soprattutto grazie al suo elevato tenore proteico oltre che alla presenza di numerose vitamine essenziali e minerali. La Spirulina platensis, infatti, ? costituita per il 55-70% da proteine, il 15-25% da carboidrati (inclusa la frazione polisaccaridica) e per il 18% da lipidi, componenti calcolati in percentuale in peso sulla materia essiccata. Essa contiene inoltre diverse vitamine, aminoacidi e minerali. All?interno della frazione proteica si trova, in una quantit? attorno all?11% sul peso secco, il costituente che ne determina la tipica colorazione azzurra: la ficocianina. A questa molecola vengono attribuite diverse propriet? benefiche per il corpo umano, legate in particolar modo alla sua capacit? di stimolare il sistema immunitario e all?elevato potere antiossidante. Today ? known and used throughout the world as a food supplement, above all thanks to its high protein content as well as the presence of numerous essential vitamins and minerals. Spirulina platensis, in fact, ? made up of 55-70% proteins, 15-25% carbohydrates (including the polysaccharide fraction) and 18% lipids, components calculated as a percentage by weight of the dried material. It also contains various vitamins, amino acids and minerals. Inside the protein fraction is found, in a quantity? around 11% of dry weight, the constituent that determines its typical blue colour: phycocyanin. Various properties are attributed to this molecule? beneficial for the human body, especially related to its ability to to stimulate the immune system and to the high antioxidant power.
In letteratura scientifica si possono ritrovare numerosi studi che riguardano l?utilizzo della Spirulina platensis per il trattamento di varie patologie, si veda ad esempio la review di Mishra T. et al. ?Spirulina: the beneficial Algae? Int. J. of Applied Microbiology Science 2013; 2(3), pag 21-35. L?alga spirulina ? stata inoltre studiata in vitro per la sua attivit? antivirale nei confronti dell'HIV e di altri patogeni, e come agente chelante con funzione antiproliferativa. In particolare, ? noto che l?estratto polisaccaridico ottenuto da questo microorganismo ha numerose attivit? biologiche e ne sono state studiate le propriet? curative ad esempio come antitumorale (Mathew B. et al. ?Evaluation of chemoprevention of oral cancer with Spirulina fusiformis? J. of Nutrition and Cancer 1995; 24(2), pag 197-202), radioprotettivo (Mart?nez E. et al. ?Subchronic toxicity study in mice fed Spirulina? J. of Ethnopharmacology 1998; 62(3), pag 235?191) e ipocolesterolemizzante (Ramamoorthy A. and Premakumari S. ?Effect of supplementation of Spirulina on hypercholesterolemic patients? J. of Food Science and Technology 1996; 33(2), pag 119?128). Numerous studies concerning the use of Spirulina platensis for the treatment of various pathologies can be found in scientific literature, see for example the review by Mishra T. et al. ?Spirulina: the beneficial Algae? Int. J. of Applied Microbiology Science 2013; 2(3), pages 21-35. Spirulina algae? has also been studied in vitro for its activity? antiviral against HIV and other pathogens, and as a chelating agent with antiproliferative function. In particular, ? it is known that the polysaccharide extract obtained from this microorganism has numerous biological and have been studied the properties? curative for example as anticancer (Mathew B. et al. ?Evaluation of chemoprevention of oral cancer with Spirulina fusiformis? J. of Nutrition and Cancer 1995; 24(2), pag 197-202), radioprotective (Mart?nez E. et al. ?Subchronic toxicity study in mice fed Spirulina? J. of Ethnopharmacology 1998; 62(3), pag 235?191) and hypocholesterolemic (Ramamoorthy A. and Premakumari S. ?Effect of supplementation of Spirulina on hypercholesterolemic patients? J. of Food Science and Technology 1996; 33(2), p. 119?128).
CN101444480 descrive e rivendica l?impiego della sola frazione polisaccaridica estratta da Spirulina platensis nel trattamento delle malattie neovascolari dell?occhio, in particolare per la soppressione dell?angiogenesi. I polisaccaridi sono formulati in gocce oculari, a concentrazioni di 10-500 ?g/ml, preferibilmente di 100 ?g/ml. CN101444480 describes and claims the use of the single polysaccharide fraction extracted from Spirulina platensis in the treatment of neovascular diseases of the eye, in particular for the suppression of angiogenesis. The polysaccharides are formulated in eye drops, at concentrations of 10-500 ?g/ml, preferably 100 ?g/ml.
CN103040735 descrive e rivendica l?impiego della sola frazione polisaccaridica estratta da Spirulina platensis nel trattamento e nella prevenzione delle cheratiti batteriche dell?occhio. In questo documento i polisaccaridi vengono formulati in gocce oculari, a concentrazioni di 100 ?g/ml. CN103040735 describes and claims the use of the single polysaccharide fraction extracted from Spirulina platensis in the treatment and prevention of bacterial keratitis of the eye. In this document the polysaccharides are formulated in eye drops, at concentrations of 100 µg/ml.
Tra le svariate patologie dell?occhio note ? compresa quella definita ?dell?occhio secco? ed ? altres? noto che i soggetti portatori di lenti a contatto necessitano spesso di una quotidiana idratazione dell?occhio. Among the various known eye diseases? including that defined? Dry eye? and ? otherwise? I know that contact lens wearers often need daily eye hydration.
Esiste una costante necessit? di poter avere a disposizione delle composizioni per l?utilizzo oculare topico che siano efficaci e al contempo sicure. Is there a constant need? to be able to have available compositions for topical ocular use that are effective and safe at the same time.
SCOPI DELL?INVENZIONE OBJECTS OF THE INVENTION
Scopo della presente invenzione ? fornire una composizione oftalmica liquida comprendente un estratto acquoso di Spirulina platensis. Purpose of the present invention? to provide a liquid ophthalmic composition comprising an aqueous extract of Spirulina platensis.
Ulteriore scopo dell?invenzione ? l?uso di detta composizione oftalmica liquida nelle patologie dell?occhio e/o come collirio e/o come lacrime artificiali da utilizzare in svariate patologie dell?occhio, ad esempio, nel trattamento dei sintomi di secchezza oculare quali dolore, prurito, bruciore oculare o sensazione di corpo estraneo negli occhi. Questi sintomi possono essere di qualsiasi origine, ad esempio possono essere causati da fattori esterni, quali aria condizionata, inquinamento, viaggi in aereo, lavoro su videoterminali, chirurgia refrattiva, uso di lenti a contatto, o da patologie, come la disfunzione delle ghiandole di Meibomio, ecc.. Another purpose of the invention? the use of said liquid ophthalmic composition in eye diseases and/or as eye drops and/or as artificial tears to be used in various eye diseases, for example, in the treatment of dry eye symptoms such as pain, itching, burning eyes or foreign body sensation in the eye. These symptoms can be of any origin, for example they can be caused by external factors, such as air conditioning, pollution, air travel, VDU work, refractive surgery, use of contact lenses, or by pathologies, such as dysfunction of the Meibomian, etc..
? un ulteriore scopo dell?invenzione fornire l?uso di un estratto acquoso della Spirulina platensis in svariate patologie oftalmiche. ? a further object of the invention is to provide the use of an aqueous extract of Spirulina platensis in various ophthalmic pathologies.
DESCRIZIONE DELL?INVENZIONE DESCRIPTION OF THE INVENTION
La presente invenzione ha per oggetto una composizione oftalmica liquida comprendente un estratto acquoso di Spirulina platensis e almeno un veicolo oftalmicamente accettabile. The present invention relates to a liquid ophthalmic composition comprising an aqueous extract of Spirulina platensis and at least one ophthalmically acceptable vehicle.
La Spirulina platensis (qui anche denominata ?microorganismo?) ? nota alla tecnica. Spirulina platensis (here also called ?microorganism?) ? technical note.
Per ?oftalmicamente accettabile? si intende qui indicare che detta composizione ? adatta alla somministrazione nell?occhio e non causa danni o disturbi. L?espessione ?estratto acquoso di Spirulina platensis? ? nota all?esperto del ramo; detto estratto acquoso comprende i diversi componenti della frazione solubile in acqua della Spirulina platensis, in particolare le proteine, inclusa la ficocianina, le vitamine e gli aminoacidi solubili, i minerali. For ?ophthalmically acceptable? is meant here to indicate that said composition? suitable for administration into the eye and does not cause damage or discomfort. The expression ?aqueous extract of Spirulina platensis? ? known to the expert in the field; said aqueous extract comprises the various components of the water-soluble fraction of Spirulina platensis, in particular the proteins, including phycocyanin, vitamins and soluble amino acids, minerals.
Diverse tecniche per la preparazione di estratti acquosi di Spirulina platensis sono note all?esperto del ramo. Various techniques for the preparation of aqueous extracts of Spirulina platensis are known to the person skilled in the art.
Ad esempio, un estratto acquoso pu? essere ottenuto sottoponendo la biomassa contente Spirulina platensis ad un ciclo termico che comprende: la sua iniziale conservazione ad una temperatura da -10 a -30?C, preferibilmente -20?C, per circa 10 giorni e un successivo riscaldamento, per esempio in stufa, ad una temperatura da 45 a 55?C, preferibilmente 50?C, per circa 3 giorni. Al termine di questo ciclo la biomassa viene filtrata attraverso un filtro opportuno, ad esempio un filtro di cellulosa da 10 ?m. L?estratto acquoso cos? ottenuto, definito anche ?estratto acquoso concentrato? costituisce il principio attivo della composizione dell?invenzione. For example, an aqueous extract can be obtained by subjecting the biomass containing Spirulina platensis to a thermal cycle which includes: its initial conservation at a temperature of -10 to -30?C, preferably -20?C, for about 10 days and subsequent heating, for example in a stove , at a temperature ranging from 45 to 55°C, preferably 50°C, for about 3 days. At the end of this cycle the biomass is filtered through a suitable filter, for example a 10 µm cellulose filter. The aqueous extract cos? obtained, also called ?concentrated aqueous extract? constitutes the active principle of the composition of the invention.
Secondo una forma di realizzazione, detto estratto acquoso ? l?unico principio attivo contenuto nella composizione dell?invenzione ma, se desiderato o necessario, a detta composizione possono essere aggiunti altri attivi. According to one embodiment, said aqueous extract ? the only active ingredient contained in the composition of the invention but, if desired or necessary, other active ingredients can be added to said composition.
Per la sua somministrazione, l?estratto acquoso di Spirulina platensis viene diluito da 30 a 100 volte (volume/volume), preferibilmente da 40 a 60 volte, in un opportuno veicolo liquido adatto alla somministrazione oculare, preferibilmente avente un pH compreso tra 6,5 e 7,5. Tale veicolo liquido pu? essere ad esempio costituito da una soluzione tampone del tipo comunemente impiegato per uso oftalmico, preferibilmente tamponi borati o fosfati, acido borico o la coppia sodio borato/acido borico. La soluzione tamponata e diluita cos? ottenuta, che costituisce una composizione oftalmica dell?invenzione, pu? essere confezionata in contenitori di tipo mono-dose o multi-dose adatti alla somministrazione oftalmica. For its administration, the aqueous extract of Spirulina platensis is diluted from 30 to 100 times (volume/volume), preferably from 40 to 60 times, in a suitable liquid vehicle suitable for ocular administration, preferably having a pH between 6, 5 and 7.5. This liquid vehicle can? be for example constituted by a buffer solution of the type commonly used for ophthalmic use, preferably borate or phosphate buffers, boric acid or the pair sodium borate/boric acid. The buffered and diluted solution so? obtained, which constitutes an ophthalmic composition of the invention, can? be packaged in single-dose or multi-dose type containers suitable for ophthalmic administration.
Secondo una forma di realizzazione, la suddetta composizione oftalmica liquida contenente la frazione di estrazione acquosa di Spirulina platensis, pu? essere ulteriormente addizionata con una frazione di estrazione lipidica del microorganismo, ottenuta con le tecniche note all?esperto del ramo, preferibilmente in una quantit? scelta dallo 0,5 all?1% peso/volume totale della composizione. According to one embodiment, the above liquid ophthalmic composition containing the aqueous extraction fraction of Spirulina platensis, can be further added with a lipid extraction fraction of the microorganism, obtained with the techniques known to the person skilled in the art, preferably in an amount selected from 0.5 to 1% total weight/volume of the composition.
Secondo una forma di realizzazione, in alternativa o in aggiunta, anche una frazione polisaccaridica della Spirulina platensis, ottenuta con le tecniche note all?esperto del ramo, pu? essere addizionata alla composizione oftalmica liquida dell?invenzione, preferibilmente in una quantit? scelta dallo 0,5 all?1% peso/volume totale della composizione. According to an embodiment, alternatively or additionally, also a polysaccharide fraction of Spirulina platensis, obtained with the techniques known to the person skilled in the art, can be added to the liquid ophthalmic composition of the invention, preferably in a quantity? selected from 0.5 to 1% total weight/volume of the composition.
Le composizioni dell?invenzione che comprendono anche dette ulteriori frazioni estratte da Spirulina platensis sono qui definite ?Composizioni oftalmiche a base di estratto acquoso composto di Spirulina platensis?. The compositions of the invention which also comprise said further fractions extracted from Spirulina platensis are defined herein as ?Ophthalmic compositions based on compound aqueous extract of Spirulina platensis?.
L?aggiunta di dette ulteriori frazioni conferisce alla composizione dell?invenzione un aumentato potere antiinfiammatorio. The addition of said further fractions gives the composition of the invention an increased anti-inflammatory power.
Dette ulteriori frazioni estratte dalla Spirulina platensis possono essere ottenute, come detto, con qualunque tecnica nota all?esperto del ramo; ad esempio la frazione lipofila pu? essere ricavata per trattamento della biomassa con etanolo e successiva filtrazione mentre la frazione polisaccaridica pu? essere ottenuta a partire dalla biomassa in seguito ad un trattamento per un periodo di 1,5-3 ore, preferibilmente 2 ore, ad una temperatura di 90-120?C, preferibilmente 100?C, seguita da una precipitazione in cetiltrimetilammonio bromuro (CTAB) all?1% ad una temperatura compresa da 0 a 6?C, preferibilmente 4?C, e successivo lavaggio del precipitato con una miscela di acetato di sodio ed etanolo (in un rapporto pari a 10/90 peso/volume). Degli esempi di estrazione delle varie frazioni sono riportati nella Sezione Sperimentale a titolo puramente illustrativo. Said further fractions extracted from Spirulina platensis can be obtained, as mentioned, with any technique known to the person skilled in the art; for example, the lipophilic fraction can? be obtained by treatment of the biomass with ethanol and subsequent filtration while the polysaccharide fraction can? be obtained starting from the biomass following a treatment for a period of 1.5-3 hours, preferably 2 hours, at a temperature of 90-120°C, preferably 100°C, followed by a precipitation in cetyltrimethylammonium bromide (CTAB ) at 1% at a temperature ranging from 0 to 6°C, preferably 4°C, and subsequent washing of the precipitate with a mixture of sodium acetate and ethanol (in a ratio equal to 10/90 weight/volume). Examples of extraction of the various fractions are reported in the Experimental Section for purely illustrative purposes.
Se desiderato o necessario, oltre alle ulteriori frazioni di Spirulina platensis sopra indicate, altri principi attivi adatti al trattamento delle patologie oculari possono altres? essere aggiunti alla composizione dell?invenzione. If desired or necessary, in addition to the additional fractions of Spirulina platensis indicated above, other active ingredients suitable for the treatment of eye diseases can also be added to the composition of the invention.
Se desiderato o necessario, la composizione dell?invenzione pu? comprendere uno o pi? eccipienti oftalmicamente accettabili, quali ad esempio acido ialuronico o omega 3. If desired or necessary, the composition of the invention can include one or more ophthalmically acceptable excipients, such as for example hyaluronic acid or omega 3.
Secondo una forma di realizzazione preferita, la composizione dell?invenzione ? una soluzione, vantaggiosamente una soluzione limpida. According to a preferred embodiment, the composition of the invention is a solution, advantageously a clear solution.
Se desiderato o necessario, ad esempio nel caso dello sviluppo di torbidit? all?interno della soluzione contenente la o le diverse frazioni estratte dalla Spirulina platensis, pu? essere impiegato anche un agente solubilizzante, preferibilmente una ciclodestrina, ancora pi? preferibilmente l?idrossipropil-?-ciclodestrina. Detto agente solubilizzante verr? addizionato alla composizione oftalmica liquida oggetto della presente invenzione in una quantit? compresa da 0,05 a 0,5 % peso rispetto al volume totale della composizione o comunque fino al raggiungimento di una soluzione limpida. If desired or necessary, for example in the case of the development of turbidity? within the solution containing the different fraction(s) extracted from Spirulina platensis, can? also be used a solubilizing agent, preferably a cyclodextrin, even more? preferably hydroxypropyl-?-cyclodextrin. Said solubilizing agent will come added to the liquid ophthalmic composition object of the present invention in an amount ranging from 0.05 to 0.5% by weight with respect to the total volume of the composition or in any case until a clear solution is reached.
Le composizioni dell?invenzione sono preferibilmente caratterizzate da una viscosit? che va da 1 mPa?s a 20 mPa?s, preferibilmente da 1 a 10, ancor pi? preferibilmente circa 5 mPa?s. The compositions of the invention are preferably characterized by a viscosity? that goes from 1 mPa?s to 20 mPa?s, preferably from 1 to 10, even more? preferably about 5 mPa?s.
La composizione dell?invenzione, comprendente, come componente principale, la frazione acquosa della Spirulina platensis, pu? essere impiegata nel trattamento di svariate patologie dell?occhio, ad esempio come lacrima artificiale per contrastare la sindrome dell?occhio secco, come umettante e/o per alleviare i sintomi derivanti dalla scarsa presenza di fluido nella congiuntiva, nell?uomo o nell?animale. Questi sintomi possono essere di qualsiasi origine, ad esempio possono essere causati da fattori esterni, quali aria condizionata, inquinamento, viaggi in aereo, lavoro su videoterminali, chirurgia refrattiva, uso di lenti a contatto, o da patologie, come la disfunzione delle ghiandole di Meibomio, ecc. The composition of the invention, comprising, as the main component, the aqueous fraction of Spirulina platensis, can be used in the treatment of various eye diseases, for example as an artificial tear to counteract dry eye syndrome, as a humectant and/or to relieve symptoms deriving from the lack of fluid in the conjunctiva, in humans or animals . These symptoms can be of any origin, for example they can be caused by external factors, such as air conditioning, pollution, air travel, VDU work, refractive surgery, use of contact lenses, or by pathologies, such as dysfunction of the meibomian, etc.
La composizione dell?invenzione ? altres? utile per i soggetti che indossano lenti a contatto. L?estratto acquoso di Spirulina platensis e la composizione oftalmica liquida dell?invenzione per l?uso nelle patologie dell?occhio e/o come collirio e/o come lacrime artificiali da utilizzare, ad esempio, nel trattamento dei sintomi di secchezza oculare quali dolore, prurito, bruciore oculare o sensazione di corpo estraneo negli occhi, rappresentano un ulteriore oggetto dell?invenzione. The composition of the invention ? otherwise? useful for people who wear contact lenses. The aqueous extract of Spirulina platensis and the liquid ophthalmic composition of the invention for use in eye diseases and/or as eye drops and/or as artificial tears to be used, for example, in the treatment of dry eye symptoms such as pain , itching, ocular burning or foreign body sensation in the eyes, represent a further object of the invention.
Secondo un altro dei suoi aspetti, l?invenzione ha per oggetto un metodo per il trattamento di patologie dell?occhio e/o come collirio e/o come lacrime artificiali da utilizzare ad esempio nel trattamento dei sintomi di secchezza oculare quali dolore, prurito, bruciore oculare o sensazione di corpo estraneo negli occhi, che comprende somministrare una quantit? efficace della composizione oftalmica liquida dell?invenzione a un soggetto, preferibilmente a un mammifero, preferibilmente all?essere umano. According to another of its aspects, the invention relates to a method for the treatment of eye pathologies and/or as eye drops and/or as artificial tears to be used for example in the treatment of dry eye symptoms such as pain, itching, eye burning or foreign body sensation in the eye, which includes administering a quantity efficacy of the liquid ophthalmic composition of the invention to a subject, preferably a mammal, preferably a human.
L?invenzione verr? ora descritta nella sezione sperimentale che segue, a titolo esemplificativo ed in nessun modo limitativo. The invention will come now described in the experimental section that follows, by way of example and in no way limiting.
SEZIONE SPERIMENTALE EXPERIMENTAL SECTION
Nei seguenti esempi la viscosit? ? misurata con viscosimetro Brookfield DV-II Pro equipaggiato con l?accessorio small sample adapter e girante SC4-18 a 0,1 rpm). In the following examples the viscosity? ? measured with Brookfield DV-II Pro viscometer equipped with the small sample adapter accessory and SC4-18 impeller at 0.1 rpm).
Esempio 1 ? Composizione oftalmica a base di estratto acquoso di Spirulina platensis Preparazione di un estratto acquoso di Spirulina platensis Example 1 ? Ophthalmic composition based on aqueous extract of Spirulina platensis Preparation of an aqueous extract of Spirulina platensis
L?estratto acquoso di Spirulina platensis viene ottenuto sottoponendo la biomassa in acqua ad una temperatura di -20?C per 10 giorni, e successivamente conservandola in stufa a 50?C per 3 giorni. Al termine di questo ciclo termico la biomassa viene filtrata attraverso un filtro di cellulosa da 10 ?m. The aqueous extract of Spirulina platensis is obtained by subjecting the biomass to water at a temperature of -20°C for 10 days, and subsequently keeping it in a stove at 50°C for 3 days. At the end of this thermal cycle, the biomass is filtered through a 10 µm cellulose filter.
Preparazione di una composizione secondo l?invenzione Preparation of a composition according to the invention
1 ml dell?estratto acquoso ottenuto come sopra riportato viene aggiunto a 49 ml di tampone borato 0,08 M pH 7,5 in cui sono stati preventivamente disciolti 118 mg di carbossimetilcellulosa. Si ottiene cos? una soluzione di un tenue colore azzurro/verde caratterizzata da una viscosit? dinamica a 20?C di 3,75 mPa?s. 1 ml of the aqueous extract obtained as reported above is added to 49 ml of 0.08 M borate buffer pH 7.5 in which 118 mg of carboxymethylcellulose have been previously dissolved. Is it obtained like this? a solution of a pale blue / green color characterized by a viscosity? dynamic at 20?C of 3.75 mPa?s.
Esempio 2 ? Composizione oftalmica a base di estratto acquoso di Spirulina platensis Example 2 ? Ophthalmic composition based on aqueous extract of Spirulina platensis
1 ml dell?estratto acquoso di Spirulina platensis, ottenuto come descritto nell?Esempio 1, viene aggiunto a 49 ml di tampone borato 0,08 M pH 7,5. Si ottiene cos? una soluzione di un tenue colore azzurro/verde caratterizzata da una viscosit? dinamica a 20?C di 1,29 mPa?s. 1 ml of the aqueous extract of Spirulina platensis, obtained as described in Example 1, is added to 49 ml of 0.08 M borate buffer, pH 7.5. Is it obtained like this? a solution of a pale blue / green color characterized by a viscosity? dynamic at 20?C of 1.29 mPa?s.
Esempio 3 ? Composizione oftalmica a base di estratto acquoso composto di Spirulina platensis Preparazione di un estratto lipofilo di Spirulina platensis Example 3 ? Ophthalmic composition based on aqueous extract composed of Spirulina platensis Preparation of a lipophilic extract of Spirulina platensis
Una frazione lipofila di Spirulina platensis viene ottenuta per estrazione della biomassa con etanolo e successiva filtrazione. A lipophilic fraction of Spirulina platensis is obtained by extraction of the biomass with ethanol and subsequent filtration.
Preparazione di un estratto polisaccaridico di Spirulina platensis Preparation of a polysaccharide extract of Spirulina platensis
Una frazione lipofila di Spirulina platensis viene ottenuta per estrazione della biomassa in seguito ad un trattamento per 2 ore a 100?C seguita da una precipitazione in cetiltrimetilammonio bromuro (CTAB) 1% a 4?C e successivo lavaggio del precipitato con una miscela di acetato di sodio ed etanolo (in un rapporto di 10/90 peso/volume). A lipophilic fraction of Spirulina platensis is obtained by extraction of the biomass following a treatment for 2 hours at 100°C followed by a precipitation in 1% cetyltrimethylammonium bromide (CTAB) at 4°C and subsequent washing of the precipitate with a mixture of acetate of sodium and ethanol (in a ratio of 10/90 weight/volume).
Preparazione di una composizione secondo l?invenzione Preparation of a composition according to the invention
1 ml dell?estratto acquoso di Spirulina platensis, ottenuto come descritto nell?Esempio 1, viene aggiunto a 49 ml di tampone borato 0,08 M pH 7,5 in cui sono stati preventivamente disciolti 250 mg di carbossimetilcellulosa. Si ottiene cos? una soluzione di un tenue colore azzurro/verde a cui vengono aggiunti 50 mg dell?estrazione della frazione lipofila di Spirulina platensis, e 27 mg della frazione polisaccaridica di Spirulina platensis. L?aggiunta di queste due ulteriori frazioni porta alla formazione di una sospensione che viene addizionata con 100 mg di l?idrossipropil-?-ciclodestrina. Detta aggiunta permette di ottenere nuovamente una soluzione limpida di tenue color azzurro/verde caratterizzata da una viscosit? dinamica a 20?C di 16,30 mPa?s. 1 ml of the aqueous extract of Spirulina platensis, obtained as described in Example 1, is added to 49 ml of borate buffer 0.08 M pH 7.5 in which 250 mg of carboxymethylcellulose have been previously dissolved. Is it obtained like this? a light blue/green solution to which 50 mg of the extraction of the lipophilic fraction of Spirulina platensis and 27 mg of the polysaccharide fraction of Spirulina platensis are added. The addition of these two further fractions leads to the formation of a suspension which is added with 100 mg of l?hydroxypropyl-?-cyclodextrin. Said addition allows to obtain again a clear solution of pale blue/green color characterized by a viscosity? dynamic at 20?C of 16.30 mPa?s.
Esempio 4 ? Composizione oftalmica a base di estratto acquoso composto di Spirulina platensis 0,5 ml dell?estratto acquoso di Spirulina platensis, ottenuto come descritto nell?Esempio 1, viene aggiunto a 49,5 ml di tampone borato 0,08 M pH 7,5 in cui sono stati preventivamente disciolti 100 mg di carbossimetilcellulosa. Si ottiene cos? una soluzione di un tenue colore azzurro/verde a cui vengono aggiunti 50 mg dell?estrazione della frazione lipofila e 27 mg della frazione polisaccaridica di Spirulina platensis, ottenuti come descritto nell?Esempio 3. L?aggiunta di queste due ulteriori frazioni porta alla formazione di una sospensione che viene addizionata con 56 mg di l?idrossipropil-?-ciclodestrina. Detta aggiunta permette di ottenere nuovamente una soluzione limpida di tenue color azzurro/verde caratterizzata da una viscosit? dinamica a 20?C di 3,7 mPa?s. Example 4 ? Ophthalmic composition based on aqueous extract composed of Spirulina platensis 0.5 ml of the aqueous extract of Spirulina platensis, obtained as described in Example 1, is added to 49.5 ml of borate buffer 0.08 M pH 7.5 in in which 100 mg of carboxymethylcellulose have been previously dissolved. Is it obtained like this? a solution of a pale blue/green color to which 50 mg of the extraction of the lipophilic fraction and 27 mg of the polysaccharide fraction of Spirulina platensis are added, obtained as described in Example 3. The addition of these two further fractions leads to the formation of a suspension which is added with 56 mg of l?hydroxypropyl-?-cyclodextrin. Said addition allows to obtain again a clear solution of pale blue/green color characterized by a viscosity? dynamic at 20?C of 3.7 mPa?s.
Claims (10)
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| Application Number | Priority Date | Filing Date | Title |
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| IT102020000013156A IT202000013156A1 (en) | 2020-06-03 | 2020-06-03 | LIQUID OPHTHALMIC COMPOSITION INCLUDING AN AQUEOUS EXTRACT OF SPIRULINA PLATENSIS. |
| US17/928,993 US20230218510A1 (en) | 2020-06-03 | 2021-06-02 | Liquid ophthalmic composition comprising a spirulina platensis full extract |
| EP21728939.6A EP4161484A1 (en) | 2020-06-03 | 2021-06-02 | Liquid ophthalmic composition comprising a spirulina platensis full extract |
| PCT/EP2021/064875 WO2021245179A1 (en) | 2020-06-03 | 2021-06-02 | Liquid ophthalmic composition comprising a spirulina platensis full extract |
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| IT102020000013156A IT202000013156A1 (en) | 2020-06-03 | 2020-06-03 | LIQUID OPHTHALMIC COMPOSITION INCLUDING AN AQUEOUS EXTRACT OF SPIRULINA PLATENSIS. |
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|---|---|---|---|---|
| CN101444480A (en) | 2008-12-26 | 2009-06-03 | 山东省眼科研究所 | Spirulina polysaccharide eye drop, and preparation method and application thereof |
| CN103040735A (en) | 2012-12-31 | 2013-04-17 | 山东省眼科研究所 | Spirulina polysaccharide eye drop |
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| CA2964858C (en) * | 2014-10-22 | 2023-10-24 | Raffaele Migliaccio | Combination comprising spirulina and palmitoylethanolamide and/or salts or pharmaceutically acceptable derivatives thereof and their formulations, for use in the prevention and/or in the treatment of hyperactivated tissue conditions |
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2020
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101444480A (en) | 2008-12-26 | 2009-06-03 | 山东省眼科研究所 | Spirulina polysaccharide eye drop, and preparation method and application thereof |
| CN103040735A (en) | 2012-12-31 | 2013-04-17 | 山东省眼科研究所 | Spirulina polysaccharide eye drop |
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| MARTINEZ E. ET AL.: "Subchronic toxicity study in mice fed Spirulina", J. OF ETHNOPHARMACOLOGY, vol. 62, no. 3, 1998, pages 235 - 191 |
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| ROSY ALDINA ET AL: "Effect of Spirulina platensis extract on Vascular Endothelial Growth Factor (VEGF) expression in corneal inflammation in rat (Rattus novergicus) strain wistar", EURASIAN JOURNAL OF BIOSCIENCES, vol. 13, no. 2, 1 January 2019 (2019-01-01), Izmir, pages 823 - 829, XP055776960 * |
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